NCT04781608

Brief Summary

Impairments in hearing and/or vision are common in older age. Having lived one's life as a fully sighted and hearing individual, older adults with sensory loss must come to terms with their declining capacity to interact with others and waning independence. There is ample research evidence showing that sensory loss (i.e., loss of hearing, vision or both) can be a distressful experience for older adults and their spouses, yet little has been done to understand what works in alleviating this distress or develop scalable cost-effective interventions to counter this distress or associated outcomes like depression, anxiety, poor quality of life, and lower relationship quality. In this project, the investigators will design and test an easy-to-administer, online intervention aimed at reducing emotional and marital distress in older adults with sensory loss and their spouses. The goal of the intervention will be to develop acceptance of the sensory loss through a series of Acceptance and Commitment Therapy inspired educational, self-compassion, and therapeutic activities. In prior research, acceptance has been flagged as a promising factor on which to intervene to assist older couples' emotional and marital recovery in the context of sensory loss. Thus, the investigators expect that the intervention should show encouraging results regarding the alleviation of distress in this group and contribute significantly to the psychosocial rehabilitation of older adults with sensory loss and their spouses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
662

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

January 18, 2021

Last Update Submit

November 3, 2022

Conditions

Keywords

Sensory lossHearing impairmentSight impairmentElderly couplesAge 60 or olderOnlineDigitalInterventionAcceptance and Commitment therapy

Outcome Measures

Primary Outcomes (3)

  • WHO-5 well-being

    5-item measure of general well-being (Bech, 1999, 2012)

    Within the last 2 weeks

  • Couple Satisfaction Index

    4-item measure of satisfaction with one's romantic relationship (Funk \& Rogge, 2007)

    Follow-up 1: During the last 6 weeks

  • Depression

    9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, \& Williams, 2001; Kroenke \& Spitzer, 2002)

    Within the last 2 weeks

Secondary Outcomes (2)

  • Psychological flexibility

    Follow-up 1: During the last 6 weeks

  • Communication

    Follow-up 1: During the last 6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Gains access to the digital intervention program

Behavioral: English: In It Together (IIT)

Wait-list- control group

NO INTERVENTION

Does not gain access to the intervention (until end of study)

Interventions

Digital intervention program that consists of 4 modules, to be completed 1 week apart. The modules consist of psychoeducation, as well as acceptance and commitment therapy-inspired activities.

Also known as: Danish: Sammen on Sansetab (SOS)
Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 60 years of age or older
  • Be able to read and write in Danish
  • Be in a romantic relationship of at least 1 year
  • Live together with the partner (share housing)
  • Feel either one self or one's partner has a sensory loss (hearing and/or sight) that affects day-to-day life. This sensory loss does not need to be confirmed by a health care provider.

You may not qualify if:

  • Less than 60 years of age
  • Cannot read or write in Danish
  • Not in a romantic relationship
  • Relationship length of less than 1 year
  • Not living together with the partner (not share housing)
  • Currently receiving psychological help (therapy/intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 1014, Denmark

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Camilla S Øverup, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR
  • Gert Martin Hald, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of two conditions: 1) Intervention group, which will receive access to the digital intervention program, and 2) Control group, who will not receive immediate acess to the digital intervention program. Intervention group: Participants will be asked to complete survey measures at baseline (prior to access to the 4-module digital intervention program), 6-weeks, 10 weeks, and 18 weeks. Control group: Participants will be asked to complete survey measures at baseline , 6-weeks, and 10 weeks (control group participants gain access to the digital intervention program after completion of the 10-week survey).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

January 18, 2021

First Posted

March 4, 2021

Study Start

November 22, 2021

Primary Completion

May 16, 2022

Study Completion

June 30, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

We will share all individual data, along with a data dictionary and analytic code. The data will be anonymized prior to sharing. The materials will be uploaded to a data repository (which as yet to be determined)

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
The data will be shared after June 30th, 2022.

Locations